Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00440206

Enrollment

Registered

2007-02-26

Start date

2001-09-30

Completion date

2001-12-31

Last updated

2007-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Immune Markers

Brief summary

Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral therapy.

Detailed description

Over the last several years two markers of disease have been utilized to determine if antiretroviral therapy has been successful, one is a CD4 cell count (reflects the immunocompetence of an infected individual) and a HIV viral load (a blood test used to determine the amount of HIV in the infected individual). However in patients who fail their first line of therapythe likelihood of extended resuppressing viral replication with subsequent therapies may be as low as 25-50%. This information may take several months to determine the new therapies possible continuing success. It would be preferable to have additional markers that respond to therapies in the first several weeks to such therapies, therfore possibly offering patients alternate treatment earlier without potentiatinglong term side effects and possible further drug resistance.

Interventions

None listed

Study design

Observational model

DEFINED_POPULATION

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient must be HIV infected * must be ≥18 years old * must have been taking the same combination ARV regimen (≥3 drugs) for at least 3 months. * Must be experiencing virologic failure (viral load ≥50 copies/mL on two occasions at least 2 weeks apart). * must be changed to a salvage antiretroviral regimen * Patient has to have signed and dated a full infomred consent.

Exclusion criteria

* Patient with any of the following abnormal laboratory test results in the previous 3 months: * Hemaglobin <100 g/L * Platelet count <20,000 cells/L * INR ≥3.5 IU * PTT ≥60 IU * Patient with other significant underlying disease (non-HIV) that might impact immune markers ( eg. advanced liver disease, malignancy).

Countries

Canada

Outcome results